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This study will measure how well PathFinder 1.0 detects retinal abnormalities on macular cube OCT B-scans by assessing its sensitivity and specificity.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Subjects with absence of macular abnormalities | Other | Subjects with absence of macular abnormalities |
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| Subjects with presence of macular abnormalities | Other | Subjects with presence of macular abnormalities |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PathFinder 1.0 on CIRRUS HD-OCT | Device | Participants undergo standard OCT imaging on CIRRUS HD-OCT systems, and the investigational PathFinder software analyzes the images for macular abnormalities without influencing clinical care. |
| Measure | Description | Time Frame |
|---|---|---|
| Sensitivity of PathFinder 1.0 | Sensitivity is the proportion of scans that PathFinder 1.0 correctly identifies as having any macular abnormality. | Baseline (single study visit OCT acquisition) |
| Specificity of PathFinder 1.0 | Specificity is the proportion of scans that PathFinder 1.0 correctly identifies as having no macular abnormality. | Baseline (single study visit OCT acquisition) |
| Measure | Description | Time Frame |
|---|---|---|
| Sensitivity and specificity by clinical diagnosis | Sensitivity and specificity of PathFinder 1.0, calculated separately within each PI-recorded diagnosis group. | Baseline |
| Sensitivity by macular abnormality type |
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Inclusion Criteria:
The subject population will be comprised of two groups (all categories below pertain to the central 6x6 mm macula area):
Group A
1. Subjects with absence of macular abnormalities Group B
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Patricia Sha, Optometrist | Contact | 925-307-1588 | patricia.sha@zeiss.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Retina Associates | Recruiting | Tucson | Arizona | 85704 | United States |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | May 28, 2025 | Jun 1, 2026 |
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Sensitivity of PathFinder 1.0 calculated separately for each OCT lesion type.
| Baseline |
| Positive Predictive Value and Negative Predictive Value | Positive Predictive Value is the proportion of B-scans called abnormal by PathFinder 1.0. | Baseline |
| Rate of acceptable versus unacceptable B-scans | Proportion of B-scans within each macular cube, and overall, that is marked as "acceptable" or "unacceptable". | Baseline |
| Algorithm repeatability (precision) | Repeatability of PathFinder 1.0 results, expressed as the consistency of the proportion of abnormal B-scans per macular cube across repeated scans. | Baseline |
| Northern California Retina Vitreous Associates | Recruiting | Mountain View | California | 94040 | United States |
|
| Premier Eyecare of San Francisco | Completed | San Francisco | California | 94110 | United States |
| Nova Southeastern University College of Optometry | Recruiting | Fort Lauderdale | Florida | 33328 | United States |
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| Eyecare Medical Group | Recruiting | Portland | Maine | 04102 | United States |
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| Moyes Eye Center | Recruiting | Kansas City | Missouri | 64154 | United States |
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| Prot_000.pdf |
| ID | Term |
|---|---|
| D019773 | Epiretinal Membrane |
| D001284 | Atrophy |
| ID | Term |
|---|---|
| D012164 | Retinal Diseases |
| D005128 | Eye Diseases |
| D020763 | Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |
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